Setmelanotide

Generic Name
Setmelanotide
Brand Names
Imcivree
Drug Type
Small Molecule
Chemical Formula
C49H68N18O9S2
CAS Number
920014-72-8
Unique Ingredient Identifier
N7T15V1FUY
Background

Setmelanotide is the first available treatment for patients with pro-opiomelanocortin, proprotein subilisin/kexin type 1, or leptin deficiencies. It is an agonist of the melanocortin 4 receptor. Earlier attempts at agonizing MC4R (such as LY2112688) lead to successful weight loss, but also an increase in blood pressure and heart rate. Other earlier treatment...

Indication

Setmelanotide is indicated for chronic weight management in patients 6 years and older with obesity due to pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, or leptin receptor (LEPR) deficiency as determined by an approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic...

Associated Conditions
Leptin Receptor Deficiency Obesity, Obesity, Pro-opiomelanocortin (POMC) Deficiency Obesity, Proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency obesity
Associated Therapies
Chronic Weight Management therapy
Clinical Trials
Related News

Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity

First Posted Date
2017-09-19
Last Posted Date
2023-05-23
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
15
Registration Number
NCT03287960
Locations
🇳🇱

Erasmus Medical Center, Rotterdam, Netherlands

🇩🇪

University of Ulm, Ulm, Germany

🇨🇦

Markham Stouffville Hospital, Markham, Ontario, Canada

and more 3 locations

Setmelanotide in a Single Patient With Partial Lipodystrophy

Phase 2
Completed
Conditions
Hypertriglyceridemia
Obesity
Interventions
Drug: Setmelanotide
First Posted Date
2017-08-25
Last Posted Date
2022-01-04
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
1
Registration Number
NCT03262610
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity

First Posted Date
2017-01-06
Last Posted Date
2023-08-18
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
213
Registration Number
NCT03013543
Locations
🇺🇸

AXIS South Florida Clinical Trials, Hialeah, Florida, United States

🇺🇸

Synexus Clinical Research US, Inc. - Akron, Akron, Ohio, United States

🇺🇸

Baylor College of Medicine, Houston, Texas, United States

and more 54 locations

Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity

First Posted Date
2016-09-12
Last Posted Date
2023-09-21
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
15
Registration Number
NCT02896192
Locations
🇩🇪

Charité Campus Virchow-Klinikum / Institute for Experimental Pediatric Endocrinology, Berlin, Germany

🇬🇧

University of Cambridge Metabolic Research Laboratories, Cambridge, United Kingdom

🇺🇸

Honor Health Research Institute, Scottsdale, Arizona, United States

and more 4 locations

Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome

Phase 2
Completed
Conditions
Prader-Willi Syndrome
Interventions
Drug: Placebo
Drug: Setmelanotide
First Posted Date
2014-12-08
Last Posted Date
2023-07-27
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
40
Registration Number
NCT02311673
Locations
🇺🇸

Kansas University Medical Center, Kansas City, Kansas, United States

🇺🇸

Winthrop University Hospital, Mineola, New York, United States

🇺🇸

University of California Irvine, Irvine, California, United States

and more 2 locations

Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients

Phase 1
Completed
Conditions
Overweight and Obesity
Interventions
Drug: Setmelanotide
Drug: Placebo
First Posted Date
2014-01-20
Last Posted Date
2023-08-07
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
99
Registration Number
NCT02041195

Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants

Phase 2
Completed
Conditions
Overweight
Interventions
Drug: Setmelanotide
Drug: Placebo
First Posted Date
2012-12-13
Last Posted Date
2023-08-14
Lead Sponsor
Rhythm Pharmaceuticals, Inc.
Target Recruit Count
74
Registration Number
NCT01749137
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